Various stents are known in the art. Typically, stents are generally tubular in shape, and are expandable from a relatively small, unexpanded diameter to a larger, expanded diameter. For implantation, the stent is typically mounted on the end of a catheter, with the stent being held on the catheter at its relatively small, unexpanded diameter. By the catheter, the unexpanded stent is directed through the lumen to the intended implantation site. Once the stent is at the intended implantation site, it is expanded, typically either by an internal force, for example by inflating a balloon on the inside of the stent, or by allowing the stent to self-expand, for example by removing a restraining sleeve from around a self-expanding stent, allowing the stent to expand outwardly. In either case, the expanded stent resists the tendency of the vessel to re-narrow, thereby maintaining the vessel's patency.
U.S. Pat. No. 5,733,303 to Israel et al. (“'303”), which is expressly incorporated by reference, shows a unique stent formed of a tube having a patterned shape which has first and second meander patterns having axes extending in first and second directions. The second meander patterns are intertwined with the first meander patterns to form flexible cells. Stents such as this one are very flexible in their unexpanded state such that they can be tracked easily down tortuous lumens. Upon expansion, these stents provide excellent radial support, stability, and coverage of the vessel wall. These stents are also conformable, in that they adapt to the shape of the vessel wall during implantation. It is readily apparent that, by nature, when the stent shown, for example in FIG. 8 thereof, is expanded in a curved lumen, cells on the outside of the curve increase in longitudinal length, but decrease in circumferential width, whereas cells on the inside of the curve decrease in longitudinal length, but increase in circumferential width to maintain a density of stent element area which is much more constant than otherwise between the inside and the outside of the curve.
One feature of stents with a cellular mesh design such as this one, however, is that they have lower longitudinal flexibility after expansion, which may be a disadvantage in particular applications. This lower longitudinal flexibility may cause stress points at the end of the stent and along the length of the stent. Conventional mesh stents like that shown in U.S. Pat. No. 4,733,665 may simply lack longitudinal flexibility, which is illustrated by FIG. 1, a schematic diagram of a conventional stent 202 in a curved vessel 204.
To implant an expandable stent, it may be delivered to a desired site by a balloon catheter when the stent is in an unexpanded state. The balloon catheter is then inflated to expand the stent, affixing the stent into place. Due to the high inflation pressures of the balloon—up to 20 atm—the balloon causes the curved vessel 204 and even a longitudinally flexible stent to straighten when it is inflated. If the stent, because of the configuration of its mesh is or becomes relatively rigid in the longitudinal axis after expansion, then the stent remains or tends to remain in the same or substantially the same shape after deflation of the balloon. However, the artery attempts to return to its natural curve (indicated by dashed lines) in FIG. 1 with reference to a conventional mesh stent. The mismatch between the natural curve of the artery and the straightened section of the artery with a stent may cause points of stress concentration 206 at the ends of the stent and stress along the entire stent length. The coronary vasculature can impose additional stress on stents because the coronary vasculature moves relatively significant amounts with each heartbeat. For illustration purposes, the difference between the curve of the vessel and the straightened stent has been exaggerated in FIG. 1.
U.S. Pat. No. 5,807,404 to Richter, which is expressly incorporated by reference, shows another stent which is especially suited for implantation into curved arterial portions or ostial regions. This stent can include sections adjacent the end of the stent with greater bending flexibility than the remaining axial length of the stent. While this modification at the end of the stent alleviates the stress at the end points, it does not eliminate the stress along the entire length of the stent.
Various stents are known that retain longitudinal flexibility after expansion. For example, U.S. Pat. Nos. 4,886,062 and 5,133,732 to Wiktor (“the Wiktor '062 and '732 patents”) show various stents formed of wire wherein the wire is initially formed into a band of zig-zags forming a serpentine pattern, and then the zig-zag band is coiled into a helical stent. The stents are expanded by an internal force, for example by inflating a balloon.
The coiled zig-zag stents that are illustrated in FIGS. 1 through 6 of the Wiktor '062 and '732 patents are longitudinally flexible both, in the expanded and unexpanded condition, such that they can be tracked easily down tortuous lumens and such that they conform relatively closely to the compliance of the vessel after deployment. While these stents are flexible, they also have relatively unstable support after expansion. Furthermore, these stents leave large portions of the vessel wall uncovered, allowing tissue and plaque prolapse into the lumen of the vessel.
Thus, it is desired to have a stent which exhibits longitudinal flexibility before expansion such that it can easily be tracked down tortuous lumens and longitudinal flexibility after expansion such that it can comply with the vessel's natural flexibility and curvature while still providing continuous, stable coverage of a vessel wall that will minimize tissue sag into the lumen.
In addition to flexibility and vessel wall support, stents have been designed with the goal of delivering agents to a site for a variety of purposes, e.g. addressing the problem of restenosis and/or thrombosis. Thus, for example, stents may be coated or filled with various compounds and therapeutic agents to enhance their effectiveness.
Various methods have been employed to apply coatings to stents. U.S. Pat. No. 5,464,650 to Berg, for example, describes a method of applying a solution to the tissue-contacting surface of the stent that includes a solvent, a polymer and a therapeutic substance. The solvent evaporates once the solution is applied to the stent, leaving behind the polymer and the therapeutic agent for the treatment of the vessel wall of the lumen upon deployment of the stent. Other coating processes known in the art include, for example, U.S. Pat. No. 6,120,847 to Yang and U.S. Pat. No. 7,604,831 to Pacetti. However, such coating processes may result in surface imperfections, including uneven coating, dripping and cracking of the coating, which may cause adverse effects such as the delivery of ineffective or toxic doses of drugs at the treatment site. Moreover, stent coating increases the effective stent thickness and may increase trauma to the vessel lumen during implantation while reducing the flow cross-section of the lumen after implementation.
Other methods for drug delivery via the stent are known in the art. For example, U.S. Pat. No. 7,208,010 to Shanley describes a stent having widened struts with through-openings containing beneficial agents. The widened struts form substantially rigid segments connected to one another by ductile hinges, resulting in an articulated stent design that suffers from limited flexibility during delivery and upon deployment of the stent. Another disadvantage of such an articulated stent design is lack of treatment uniformity across the length of the stent between rigid segments and regions of flexibility.
Thus, it is desired to have a stent capable of delivering such agents without increasing the effective wall thickness of the stent, and without adversely impacting the maneuverability before expansion or flexibility, uniformity of vessel wall coverage or radial support upon deployment.